Kornimate/medical-research-clean huggingface dataset:
posaconazole prophylaxis for capa prevention in critically-ill patients

Conditions: COVID-19 Respiratory Infection; Aspergillosis

Summary: covid-19 associated pulmonary aspergillosis (capa) is considered a potentially life-threatening infection in critically ill covid (corona virus disease)-19 patients. this study will investigate the efficacy of mold-active prophylaxis with posaconazole for patients with severe sars (severe acute respiratory syndrome)-cov-2 infection admitted to the icu (intensive care unit) in a multi-center case-control study in europe.


Eligibility criteria:
inclusion criteria: * adult patient (\> 18 years) * pcr (polymerase chain reaction) -confirmed sars-cov-2 infections based on nasopharyngeal swab (nps), oropharyngeal swab (ops), tracheal aspirate (ta), bronchial aspirate (ba), or bronchoalveolar lavage fluid (balf) within 14 days prior to icu admission or within 72 hours following icu admission due to severe covid-19 infection * radiographic imaging consistent with sars-cov-2 infection (e.g. atypical pneumonia, organizing pneumonia, ground glass opacities) or ards within 7 days of diagnosis of sars-cov-2 infection exclusion criteria: * patients with a diagnosis of invasive aspergillosis/detection of aspergillus spp. by culture from sputum, ta, ba, or balf or positive gm from serum, ta, or balf at baseline (=icu admission) * history of invasive aspergillosis within the prior six months * patients that are being treated with mold-active antifungal agents for invasive aspergillosis or another invasive fungal infection * patients that are being treated with mold-active antifungal agents for invasive aspergillosis or another invasive fungal infection * death or transfer to general ward within 48 hours of icu admission * antifungal prophylaxis other than posaconazole (e.g. inhaled amphotericin b)
b3 buddy for securing urinary drainage bag to patient while walking

Conditions: Urinary System Disorder

Summary: this clinical trial tests how well the bag below bladder (b3) buddy device works in securing urinary drainage bags while walking. keeping a urinary drainage bag below the bladder is the standard of care to maintain urine flow and prevent urine from backing up into the bladder. despite the use of modern urinary drainage bags for over 60 years, workarounds, including hooking the bag into pants pockets, are being used to secure the bags while walking. the b3 buddy may help keep the urinary drainage bag at the proper level for drainage while walking.

primary objectives: i. to evaluate the acceptability of the b3 buddy, from the patient's perspective. ii. to evaluate the usability of the b3 buddy, from the clinician's perspective. outline: patients are assigned to 1 of 2 groups. patients: patients receive a short instructional session, wear the b3 buddy device to secure urinary drainage bag and walk approximately 90 feet before urinary drainage bag is returned to the standard position on study. clinicians: clinicians receive a short instructional session, secure the urinary drainage bag to the patient using the b3 buddy device. clinicians also assist patient with walking and then remove the device and return urinary drainage bag to the standard position on study.

Eligibility criteria:
inclusion criteria: * patient participant: must be english-speaking * patient participant: able to comprehend and agree to consent * patient participant: able to read and complete the acceptability of implementation measure (aim) survey * patient participant: be willing to participate using the b3 buddy device * patient participant: have an indwelling urinary catheter or urostomy device connected to a drainage bag * patient participant: have no restrictions in ambulation * clinician participant: must be english-speaking * clinician participant: able to comprehend and agree to consent * clinician participant: able to read and complete the system usability scale (sus) survey * clinician participant: be willing to participate using the b3 buddy device * clinician participant: have a professional role in assisting patients in ambulation in normal workday activities exclusion criteria: * those patient participants that have more than one urinary-like drainage bags will be excluded. this exclusion is due to the limited prototype samples available to the research team. limiting one device for one patient with multiple drainage bags may not allow for accurate assessment of the b3 buddy device
gore glaucoma drainage implant clinical study dominican republic

Conditions: Primary Open-angle Glaucoma

Summary: the objective of this early feasibility clinical study is to evaluate the safety and effectiveness of the gore glaucoma drainage implant (2 configurations) in subjects with primary open-angle glaucoma that is uncontrolled by hypotensive medications or for which conventional incisional glaucoma surgery would be more likely to fail due to scarring.


Eligibility criteria:
inclusion criteria: * males and females, age 18 to 85 years, inclusive at screening visit * a diagnosis of primary open-angle glaucoma (shaffer angle ≥ 3 as seen on gonioscopy) at screening visit * medicated intraocular pressure at screening visit and the mean medicated diurnal iop at baseline visit ≥ 18 mmhg and ≤ 40 mmhg by goldmann applanation tonometry exclusion criteria: * expected inability to implant the study device in the superotemporal quadrant (e.g., a lack of freely mobile conjunctiva to cover the entire implanted device in the superotemporal quadrant) * diagnosis of any active ocular disease or disorder (other than glaucoma) that requires treatment, where the disease or treatment could be reasonably expected to affect the vision or iop during the duration of the study * prior corneal transplant surgery (full or partial thickness transplants) or clinically significant corneal dystrophy, e.g., fuchs' dystrophy (\> 12 confluent guttae) in the study eye * concurrent cataract surgery or anticipated need for cataract surgery (i.e., clinically significant cataract) in the study eye during the 12 months following implantation * bcdva worse than 20/200 in the fellow (non-study) eye at the screening visit and bcdva of the fellow eye cannot be worse than that of the study eye.
screening of obstructive sleep apnea by smartphone homemade video in childood snoring population

Conditions: Obstructive Sleep Apnea Syndrome; Adeno-amygdala Hypertrophy; Snoring

Summary: the aim of the study is to evaluate the value of a video recording of the child sleep on smartphone made by the parents and comparing it to ventilatory polygraphy (pv) on the one hand and to the clinical evaluation method (clinical examination + spruyt and gozal score) on the other hand.

obstructive sleep apnoea syndrome (osas) is a common disorder in school-aged children with an estimated prevalence of 1-4%. the main etiology is adeno-amygdala hypertrophy. adenoamygdalectomy, which involves the removal of tonsils and adenoids, is a common procedure. in the majority of cases, it allows the healing of osas. the surgical indication is currently based on clinical arguments sensitized by the calculation of a severity score (spruyt and gozal score). however, this procedure is not without complications: pneumopathy (for 1.5% of procedures), blood transfusion for haemorrhage (1/400 to 1/2 500), death due to haemorrhage (1/35 000 to 1/50 000). currently there is no indication to perform a preoperative sleep recording for this surgery. this recording will only be made in case of associated comorbidities (obesity, craniofacial malformations, neurological disorders...). the current growth and diffusion of smartphones in the population provides a simple technical means of video recording the child's sleep. more and more parents come to an ent consultation with a video recording of their child's sleep on a smartphone. the current recommendations say to take these data into account without any study having evaluated the value of such records. the video recording of a snoring child's sleep has already been evaluated by sivan et al in 1996. this study finds a good correlation between polysomnographic recording and a method of rating video recordings of sleep in children with adeno-amygdala hypertrophy without associated comorbidities. the aim of this study is therefore to evaluate the value of this video recording on smartphone made by the parents by comparing it to ventilatory polygraphy (pv) on the one hand and to the clinical evaluation method (clinical examination + shs score) on the other hand. if our hypothesis is correct, smartphone video recording could be an additional tool to the clinical diagnosis of osa in children with adeno-amygdala hypertrophy.

Eligibility criteria:
inclusion criteria: * children between 3 and 10 years old consulting an ent for snoring noted by the entourage (parents). * tonsil hypertrophy ≥ 2 (brodsky classification). * entourage in possession of a smartphone allowing a video recording (under android format). exclusion criteria: * chronic cardiovascular, neurological, metabolic (overweight, obesity) or associated pulmonary pathology. * syndromic craniofacial malformations.

Keywords: obstructive sleep apnea syndrome adeno-amygdala hypertrophy tonsillectomy video smartphone ventilatory polygraphy
effect of eleclazine on shortening of the qt interval, safety, and tolerability in adults with long qt syndrome type 3

Conditions: Long QT Syndrome Type 3

Summary: the primary objective of this study is to evaluate the effect of oral eleclazine on mean daytime qtcf interval after 24 weeks of treatment with elecalzine in participants with long qt syndrome type 3. during the single-blind treatment period (24 weeks), participants will receive eleclazine and/or eleclazine placebo. following the single-blind treatment period, participants who have not permanently discontinued study drug will be eligible, at the discretion of the investigator, to continue receiving eleclazine during an open-label extension (ole) phase.


Eligibility criteria:
key inclusion criteria: * individuals with an established diagnosis of lqt3 (by genotype testing) * mean (of triplicate) qtc interval ≥ 480 msec (or ≥ 460 msec, for individuals who are currently taking ranolazine or class i antiarrhythmic drugs such as mexiletine) at 3 or more time points, determined by standard 12-lead ecg, at screening key exclusion criteria: * known mutations associated with type 1 long qt syndrome (lqt1) or type 2 long qt syndrome (lqt2) * known or suspected history of seizures or epilepsy * history of heart failure defined as new york heart association (nyha) class iv and/or known left ventricular ejection fraction (ef) ≤ 45% * body mass index (bmi) ≥ 40 kg/m\^2 at screening * severe renal impairment at screening (defined as an estimated glomerular filtration rate (egfr) \< 30 ml/min/1.73m\^2, using the 4 variable modification of diet in renal disease (mdrd) equation, as determined by the study center) * abnormal liver function tests at screening, defined as alanine aminotransferase (alt) or aspartate aminotransferase (ast) \> 2 x upper limit of normal (uln), or total bilirubin \> 1.5 x uln * an aborted cardiac arrest (aca), implantable cardioverter-defibrillator (icd) implantation, syncopal episode, or appropriate icd therapy within 3 months prior to screening * any other condition or circumstance that in the opinion of the investigator would preclude compliance with the study protocol note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: type 3 long qt syndrome (lqt3) long qt syndrome congenital long qt sudden cardiac death
estrogen use in protection from cognitive decline

Conditions: Aging; Menopause

Summary: this study is designed to assess the effects of estrogen therapy among postmenopausal women at risk for cognitive decline.

a total of 71 postmenopausal women ages 50-65 on estrogen therapy will be randomized to continue or discontinue use of estrogen and will be followed for two years. participants will undergo pet and mri scans and neuropsychological assessments initially and at the end of the two-year follow-up period. these procedures will allow us to evaluate brain metabolism and cognitive performance at baseline and two years following continuation or discontinuation of estrogen therapy. we hypothesize that women who discontinue estrogen will show more evidence of decline than those who continue estrogen. this project will expand current knowledge of effects of estrogen by 1) determining whether estrogen use among postmenopausal women at risk for cognitive decline is protective of brain metabolism, 2) identifying early predictors for cognitive decline, and 3) developing guidelines for estrogen use in postmenopausal women.

Eligibility criteria:
inclusion criteria: * women between the ages of 45 and 65 * currently on hormone replacement * one year or more post complete cessation of menses * willing to sign the human subject protection consent form prior to enrollment in the study * willing to be randomized to continue or discontinue estrogen therapy * adequately visually and auditorially acute to allow neuropsychological testing * beyond 8 years of educational achievement to allow adequate neuropsychological testing * willing to undergo brain imaging * at risk for cognitive decline, as defined by one or more of the following: personal or family history of mood disorder, hypothyroidism, diabetes, family history of alzheimer's, apoe-4 allele exclusion criteria: * diagnosis of possible or probable alzheimer's disease or dementia * cerebrovascular disease or uncontrolled hypertension (systolic bp \>170 or diastolic bp \>100) * history of myocardial infarction within previous year or unstable heart disease * history of significant liver disease, pulmonary disease, or current cancer * contraindication for mri (metal in body, claustrophobia, etc.)

Keywords: aging menopause estrogen replacement therapy cognitive decline
primary prevention of hypertension in obese adolescents

Conditions: Obesity; Pre-Hypertension; Hyperuricemia

Summary: the purpose of this study is to examine the consequences of lowering serum uric acid in pre-hypertensive, obese adolescents pathways involved with how uric acid mediated hypertension and renal disease. the specific aims are: 1. test the hypothesis that lowering uric acid will improve endothelial function. 2. test the hypothesis that lowering uric acid will reduce plasma renin activity and serum angiotensin ii levels. 3. test the hypothesis that lowering uric acid will reduce markers of inflammation

the trial will be a double blinded, placebo control trial of two uric acid lowering agents. the endpoints for this trial will be, endothelial function, systemic vascular resistance, plasma renin activity, mcp-1 and crp. upon recruitment and informed consent, children will undergo initial screening. this will include medical history, family history, dietary history, review of systems (questionnaire used and validated in pediatric hypertension clinic) and pediatric quality of life questionnaire. they will have a physical exam, casual and ambulatory blood pressure monitoring (see below) and screening laboratory analysis that will include cbc, electrolytes, bun, cr, uric acid, ast, alt and urinary micro-albumin to creatinine ratio. children with serum uric acid less than 5.0mg per dl will be enrolled as controls and only have baseline studies at screening and visit 1. children with serum uric acid equal to or greater than 5.0mg per dl will be randomized (in a one to one to one ratio) to receive placebo, allopurinol or probenecid. study drug (or placebo) will be administered for 2 months. during the first week, subjects will take one tablet (placebo, 150mg allopurinol or 250mg probenecid) twice daily. at the end of one week subjects will be instructed to increase to 2 tablets (placebo, 300mg allopurinol or 500mg probenecid) twice daily. data collection will occur during screening, after one and two months on the study drug and one month after completion of the study drug.

Eligibility criteria:
inclusion criteria: children between the ages of 11 and 18 body mass index greater than the 95th percentile for age blood pressure between 75th and 95th percentile for age, gender and height percentile exclusion criteria: hypertension at the time of screening allergy to one of the study medications liver function abnormality (ast or alt greater than twice the upper limit of normal for the laboratory) history of renal stones renal insufficiency (schwartz formula calculated gfr less than 70ml per min per 1.73m2 bsa) positive urine pregnancy test diabetes organ transplant recipient currently treated with an angiotensin converting enzyme inhibitor (acei), angiotensin receptor blocker (arb), diuretic, other medications known to alter serum uric acid level lack of ability to comply with the study protocol
a dose-finding study of ro5323441 in patients with metastatic treatment-refractory colorectal or ovarian cancer

Conditions: Colorectal Cancer, Ovarian Cancer

Summary: this exploratory, open label study will assess the the dose-effect relationship, efficacy and safety of ro5323441 in patients with metastatic treatment-refractory colorectal or ovarian cancer. cohorts of patients will receive doses of intravenous ro5323441 in the range of 25mg to 3g every 1 or 2 weeks and will undergo serial dynamic contrast-enhanced magnetic resonance imaging (dce-mri) assessments. in the absence of disease progression and unacceptable toxicity, patients may continue to receive their maximum dose of ro5323441 for a core treatment phase of up to a total of 6 months. treatment with ro5323441 can be extended at the investigator's discretion until disease progression or unacceptable toxicity occurs. target sample size is \<100.


Eligibility criteria:
inclusion criteria: * adult patients, \>/=19 years of age * metastatic or unresectable colorectal or ovarian cancer refractory to, or unsuitable for standard therapy * presence of tumor lesions suitable for dce-mri evaluation * who performance status 0-1 * adequate bone marrow, liver and renal function exclusion criteria: * patient unsuitable for mri scanning (e.g. metal implants, pacemaker, claustrophobia, hypersensitivity to dce-mri contrast material) * brain metastases * clinically significant ascites * active bleeding, bleeding diathesis, oral anti-vitamin k medication (other than low dose coumarin) or history of coagulation disorders * radiation therapy within 3 weeks, or anti-neoplastic therapy \<30 days prior to first dose of study drug * chronic therapy with systemic steroids or another immunosuppressive agent \<2 weeks prior to first dose of study drug * treated with bevacizumab in last regimen of systemic therapy
endoscopic treatment of intestinal fistulas and perforations

Conditions: Gastric Fistula

Summary: background: t-shaped tissue anchors have promise to close incisions and perforations of the intestines securely. the closure of perforations, gastro-gastric, or intestinal fistulas usually requires invasive open or laparoscopic surgery under general anesthesia and can be complex surgeries due to their reoperative or inflammatory nature. objective: the proposed use of full thickness tissue anchors adds a new surgical aspect to the endoscopic treatment of fistulas and perforations by offering a robust suture like closure of defects. instead of a 20 cm abdominal incision or 3 or 4 one centimeter incisions with the related postoperative morbidity an endoscopic technique is used which requires no postoperative limitation of activities. methods: in this study the investigators propose to use an endoscopic technique that eliminates the need for open or laparoscopic surgery and provides a more robust endoscopic repair than is possible with traditional endoscopic tools. patients who are scheduled to undergo surgery for intestinal fistulas will be screened for study eligibility. patients who are scheduled to undergo complex polypectomy, or submucosal dissection will be screened for study eligibility and informed about all possible therapies in case of an iatrogenic perforation (open - laparoscopic surgery, endoscopic clipping, endoscopic closure with tissue anchors). a commercially available flexible endoscope will be inserted through the mouth and the fistula or perforation will be closed using the tissue approximation system (ethicon endo surgery, cincinnati, oh). the investigators will initially evaluate the potential benefit, risks and impact on the patient's quality of life of this modified surgical technique in 5 patients. expected results: the potential advantages to the patients entered into this study result from the avoidance of open or laparoscopic surgery with the related risks (bleeding, injury of organs, post operative wound infection, hernia), shorter hospital stay, reduced postoperative pain, earlier return to work, and cosmetic advantage.


Eligibility criteria:
inclusion criteria: * ability to undergo general anesthesia * age \> 18 yrs. of age and \< 85 yrs. of age * ability to give informed consent exclusion criteria: * contraindicated for esophagogastroduodenoscopy (egd) * contraindicated for colonoscopy * bmi \< 40 * presence of esophageal stricture * altered gastric anatomy * intraabdominal abscess or severe inflammation * pregnancy

Keywords: gastric fistula perforation endoscopy closure endolumenal
efficacy and safety of activated recombinant human factor vii in treatment of bleeding in patients following allogeneic stem cell transplantation

Conditions: Acquired Bleeding Disorder; Bleeding During/Following Surgery

Summary: this trial is conducted in asia, europe and oceania. the aim of this trial is to evaluate the efficacy of placebo and activated recombinant human factor vii in patients having undergone allogeneic or autologous stem cell transplantation.


Eligibility criteria:
inclusion criteria: * patients who have undergone allogeneic or autologous stem cell transplantation exclusion criteria: * known or suspected allergy to trial product * participation in other trials with unapproved drugs or trials with equal or similar objective
cuirass fitting study - time for mounting and ventilation

Conditions: Airway Disease

Summary: non-invasive biphasic cuirass ventilation (bcv) has recently been described for ent surgery (ref 1-2). the clinical experience is however still sparse and further study is required. the purpose of the study is to descibe 1) mounting time and fitting of the cuirass shell on voluntary participants and 2) time to visible ventilation

the purpose of this study is to evaluate the the fitting of the cuirass shell on healthy volunteers. even though there is growing knowledge of cuirass ventilation in anaesthesia, (ref. 1-2) there is sparse experiences with the time required for fitting the cuirass shell and the time to start of ventilation. this knowledge is paramount before even discussing the potential use of cuirass ventilation in acute settings in the future. in addition to the invitation to the copenhagen airway management course in copenhagen denmark on 30th of november 2023, all participants have been invited an has accepted to participate in the study. in total 60 to 65 participants will all have the cuirass shell fitted and will be awake ventilated with biphasic cuirass ventilation. all participants have given consent to being video filmed. the study will register the time it takes to fit the cuirass shell and the time before visible ventilation is obtained. all participants will be in their habitual state i.e..no sedation is required since the product was originally designed for home use in awake patients.

Eligibility criteria:
inclusion criteria: * participants of the airway course exclusion criteria: * recent surgery in thoracic or abdominal compartments * participants with pace-maker